Osteosarcoma Clinical Trials

• Age 18 years or older.

• Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.

• Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.

• Documented disease progression radiologically after the last routine treatment.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.

• Male participants must meet at least one of the following conditions:

∙ Considered infertile;

‣ No fertile partner;

‣ Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;

∙ and

‣ Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.

• Female participants must meet at least one of the following conditions:

∙ Considered infertile;

‣ Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;

• Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.

⁃ Preserved organ functions defined by:

∙ Absolute neutrophil count ≥ 1,000;

‣ Hemoglobin ≥ 8.0 g/dL (patients may receive transfusions to reach this level);

‣ Platelet count ≥ 100,000;

‣ Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;

‣ Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);

‣ Creatinine clearance \> 30 mL/min (estimated by Cockcroft-Gault).

⁃ Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.

∙ List I:

⁃ Urachal adenocarcinoma

• Parathyroid carcinoma

• Nasopharyngeal epithelial tumors

• Fibrolamellar carcinoma of any primary site

• Angiosarcoma of any primary site

• Secretory breast carcinoma

• Anal cancer

• Metaplastic breast carcinoma

• Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency

• Carcinosarcoma of any primary site

• Small intestine cancer

• Cholangiocarcinoma

• Sertoli-Leydig cell tumors

• Cervical cancer of non-epidermoid histology

• Tracheal epithelial tumors

• Non-cystadenoma salivary gland tumors

• Mesothelioma of any site

• Neuroblastoma

• Adrenal cancer

• Penile cancer

• Apocrine carcinoma

• Fibrosarcoma of any primary site

• Cancer of unknown primary site

• Hemangioblastoma of any primary site

• Thyroid cancer

• Hepatoblastoma

• Fallopian tube cancer

• Leiomyosarcoma of any primary site

• Vaginal cancer

• Neurofibrosarcoma of any primary site

• Gallbladder cancer

• Osteosarcoma of any primary site

• Bile duct cancer

• Clear cell endometrial carcinoma

• Yolk sac tumor of any primary site

• Non-epidermoid bladder cancer

• Vulvar cancer

• Kaposi's sarcoma

• Epithelial ovarian cancer

• Soft tissue sarcoma

• Urethral cancer

• Granulosa cell tumor of any primary site

• Cystadenoma carcinoma

• Primitive neuroectodermal tumor of any primary site

• Pure or mixed neuroendocrine tumors with neuroendocrine component

• Trophoblastic tumor